MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....an internal reservoir containing sufficient formulation for multiple doses that are.....recommended for inclusion in the application regarding the components, manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

/a//content.14388
...Mixing, granulating, milling, molding, of components, drug product containers, formulating, lyophilizing.....Therefore, under the Federal Food, all established standards, specifications, Drug, and.....characteristics, formulation, equipment, to human or animal health or if there are.. (b..
http://www.fda.gov/cder/dmpq/fr5396.pdf (score=585)

Sterile Drug Products Produced by Aseptic Processing
...Drug product components, containers, closures, storage time limitations, and manufacturing equipment.....Components and drug product containers and closures shall at all times be handled and stored in a manner to.....formulation processing stage.  The total time for product filtration should be limited to..
http://www.fda.gov/cder/guidance/5882fnl.htm (score=222)

HUMAN DRUG CGMP NOTES March 1997
...Welcome to another edition of Human Drug CGMP Notes, our periodic memo on CGMP for human.....First is the microbial specification of the finished product or the equipment surfaces.....84(c)(6), Testing and approval or rejection of components, drug product containers, and..
http://www.fda.gov/cder/hdn/cnotes37.htm (score=193)

Guidance for Industry
...products shall be excluded from direct contact with components, drug product containers, closures, in.....Direct inoculation into the drug formulation provides an assessment of the effect of drug.....prevent the contamination of equipment, components, drug product containers, closures..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=172)

Guidance for Industry
...products shall be excluded from direct contact with components, drug product containers, closures, in.....Direct inoculation into the drug formulation provides an assessment of the effect of drug.....prevent the contamination of equipment, components, drug product containers, closures..
http://www.fda.gov/cder/guidance/1874dft.pdf (score=168)

...84 pertains to the testing and approval or rejection of components, drug product containers, and.....formulation, equipment, or processes, including reprocessing, that could affect product.....82 governs the receipt and storage of untested components, drug product containers, and..
http://www.fda.gov/cber/genadmin/cgmp.txt (score=133)

Document
...Mixing, granulating, milling, molding, of components, drug product containers, formulating, lyophilizing.....Therefore, under the Federal Food, all established standards, specifications, Drug, and.....characteristics, formulation, equipment, to human or animal health or if there are.. (b..
http://www.fda.gov/cber/genadmin/cgmp.pdf (score=132)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....accelerator operation, radiochemical synthesis, purification steps, and formulation of the.....evaluation can include testing of the material (see Section VI, Control of Components, 276..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=114)

Guidance For the Submission of Documentation for Sterilization Process
...other processes should be addressed as each applies to the drug product,sterile packaging and.....The sterilization and depyrogenation processes used for containers,closures, equipment.....The specific bulk drug product solution filtration processes,including tandem filter units..
http://www.fda.gov/cber/gdlns/sterval.pdf (score=84)

GUIDE TO INSPECTIONS OF DOSAGE FORM DRUG MANUFACTURER'S - CGMPR'S
...Determine the validity, and accuracy of the firm's inventory system for drug components.....Components or finished product adulterated by rodents, insects, or chemicals must be documented and submitted for.....Air supplied to the non-sterile preparation or formulation area for manufacturing..
http://www.fda.gov/ora/inspect_ref/igs/dose.html (score=84)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....accelerator operation, radiochemical synthesis, purification steps, and formulation of the.....evaluation can include testing of the material (see Section VI, Control of Components, 276..
http://www.fda.gov/cder/guidance/4259dft.PDF (score=81)

For the Submission of Documentation for Sterilization Process
...other processes should be addressed as each applies to the drug product,sterile packaging and.....The sterilization and depyrogenation processes used for containers,closures, equipment.....The specific bulk drug product solution filtration processes,including tandem filter units..
http://www.fda.gov/cder/guidance/cmc2.pdf (score=78)

...A change in the primary packaging components for any drug product when the primary packaging components control[20.....COMPONENTS AND COMPOSITION Changes in the qualitative or quantitative formulation.....Different reporting categories are recommended once CDER has reviewed certain components/materials in association with a drug product..
http://www.fda.gov/cder/guidance/3516fnl.doc (score=76)

Changes to an Approved NDA or ANDA
...This is applicable to any material where such procedures are necessary, including drug substance, drug product.....A change in the primary packaging components for any product when the primary packaging components control the dose delivered.....Changes in the qualitative or quantitative formulation, including inactive ingredients, as..
http://www.fda.gov/cder/guidance/2766fnl.htm (score=76)

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...This applies to any material where such procedures are necessary, including drug substance, drug product.....recommended once CDER has reviewed certain components/materials in association with a drug.....Changes in the qualitative or quantitative formulation, including inactive ingredients, as..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1999d-0529-gdl0003.pdf (score=76)

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...This applies to any material where such procedures are necessary, including drug substance, drug product.....recommended once CDER has reviewed certain components/materials in association with a drug.....Changes in the qualitative or quantitative formulation, including inactive ingredients, as..
http://www.fda.gov/cder/guidance/3516fnl.pdf (score=76)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...For these reasons, the drug formulation of a TDS product, including the interaction of all TDS components, is highly.....A sophisticated formulation of the drug product is required to ensure dosing accuracy and reproducibility, and.....The composition of an MDI formulation and the physicochemical content of each of the formulation..
http://www.fda.gov/cder/fdama/difconc.htm (score=47)

Premarin
...Under the Federal Food, Drug, and Cosmetic Act, for a generic drug product with Premarin as the reference listed drug to be approved.....In most cases, it will be clear what components of a drug make clinically meaningful.....This unexpected characteristic of the Premarin formulation meant that generic copies were..
http://www.fda.gov/cder/news/celetterjw.htm (score=31)

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